Medical Devices Quality Management System Manual
Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.
- Standard
- ISO 13485
- Document Type
- Manual
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Manual, Medical Devices
This Medical Devices Quality Management System Manual describes how your organisation meets the requirements of ISO 13485:2016 and applicable medical device regulations, covering the scope and any exclusions, the process approach and risk-based thinking, documentation requirements, management responsibility, resource management, product realization, and measurement, analysis and improvement. It links to the supporting procedures, registers and records.
What's Inside
- Normative References and Regulatory Requirements
- Quality Management System
- Management Responsibility
- Resource Management
- Product Realization
- Measurement, Analysis and Improvement
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 4 to 8. It fits with the rest of the QEHS Vault ISO 13485 document set.
Format
Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.
Key Benefits
- Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements
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